Note: The job is a remote job and is open to candidates in USA. Health Research, Inc. (HRI) Roswell Park Division is seeking a Technical Operations Manager to lead manufacturing operations for CAR-T and other cell therapies within its GMP Engineering & Cell Manufacturing Facility. The role oversees facility operations, process and analytical development, cGMP compliance, resource management, cross-functional coordination, and continuous improvement activities.
Responsibilities
- Leads a team of professional associates responsible for the manufacturing of CAR-T and other cell therapies within the GMP Engineering & Cell Manufacturing Facility
- Oversees the day-to-day operations of cell therapy programs, including manufacturing and facilities cleaning and maintenance
- Coordinates process and analytical development activities, ensuring compliance with cGMP (Good Manufacturing Practice) regulatory standards and safety protocols as well as managing the company’s resources effectively
- Ensures efficient production processes and effective analytical strategies and methods, coordinating with different departments, and implementing innovative approaches to improve productivity and profitability
- Works closely with the team to provide process, material, and equipment knowledge to meet customer requirements and addresses operational and routine challenges as they arise for manufacturing
- Participates and assists Technical Operations management with the preparation of budgets, statements of work, and other documents requested by internal and external customers required for reporting purposes, oversight of operations and for publication
Skills
- PhD in a health or science related field and the equivalent of three (3) years of full-time experience in GMP Manufacturing; or
- Master's degree in a health or science related field and the equivalent of five (5) years of full-time experience in GMP Manufacturing
- Degrees must be conferred by an accredited school, college, or university, or by an institution recognized by Roswell Park Comprehensive Cancer Center and/or Health Research Incorporated as adhering to acceptable educational standards
- Certified Scrum Master / Agile delivery experience (helpful for systems implementations and cross-functional execution)
- Lean Six Sigma Black Belt (or equivalent demonstrated CI leadership)
- CDMO experience, including client-facing delivery, tech transfer, and rapid timeline execution
- Experience with common quality/systems tools (e.g., TrackWise / MasterControl / similar)
Benefits
- A comprehensive benefits package
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